Table 1 Distribution of patient characteristics at baseline for Modified intent to treat (ITT, N = 890) and Per Protocol (N = 642) population who completed the treatment.

From: Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial

Characteristic(s)

Modified ITT Population (N = 890)

Per Protocol Population (N = 642)

MIP Arm, (N = 449) n (%)

Placebo Arm, (N = 441) n (%)

MIP Arm, (N = 328) n (%)

Placebo Arm, (N = 314) n (%)

Age Group

 18–30 years

249 (55.5%)

224 (50.8%)

195 (59%)

166 (53%)

 31–44 years

133 (29.6%)

154 (34.9%)

92(28%)

106 (34%)

 ≥45 years

67 (14.9%)

63 (14.3%)

41 (13%)

42 (13%)

Gender

 Male

317 (70.6%)

324 (73.5%)

225 (69%)

223 (71%)

 Female

132 (29.4%)

117 (26.5%)

103 (31%)

91 (29%)

BMI*

 <18.5

441 (98.2%)

425 (96.4%)

322 (98%)

304 (97%)

 ≥18.5

8(1.8%)

16 (3.6%)

06 (2%)

10 (3%)

Reason for Inclusion in CAT-II

 Treatment Failure in CAT-I

34 (7.6%)

24 (5.4%)

23 (7%)

11 (4%)

 Treatment after Default

189 (42.1%)

174 (39.5%)

129 (39%)

125 (40%)

 Relapse

226 (50.3%)

243 (55.1%)

176 (54%)

178 (57%)

Resistance to Drugs at Treatment Initiation

 >3 drugs

0

0

0

0

 2–3 drugs

41 (9.1%)

48 (10.9%)

16 (5%)

21 (7%)

 1 drug

84 (18.7%)

60 (13.6%)

54 (16%)

44 (14%)

 Streptomycin

40 (8.9%)

44 (10%)

24 (7%)

25 (8%)

 Isoniazid

78 (17.4%)

80 (18.1%)

43 (13%)

48 (15%)

 Rifampicin

15 (3.3%)

9 (2%)

08 (2%)

04 (1%)

 Ethambutol

40 (8.9%)

30 (6.8%)

18 (5%)

12 (4%)

 MDR#

63 (14%)

69 (15.6%)

—

—

Sputum AFB Smear Grade@

 1+

145 (32.3%)

122 (27.7%)

104 (32%)

83 (26%)

 2+

117 (26.1%)

127 (28.8%)

93 (28%)

87 (28%)

 3+

168 (37.4%)

170 (38.5%)

115 (35%)

128 (41%)

 Sc

19 (4.2%)

22 (5%)

16 (5%)

16 (5%)

Chest Radiography at Treatment Initiation

 Bilateral cavitations

353 (78.6%)

336 (76.2%)

248 (76%)

233 (74%)

 Unilateral cavitation

96 (21.4%)

105 (23.8%)

80 (24%)

81 (26%)

 No cavitation

—

—

—

—

Radiographic Severity of Disease at

 Initiation$

54 (12%)

57 (12.9%)

40 (12%)

40 (13%)

 Minimal

306 (68.2%)

304 (68.9%)

228 (70%)

220 (70%)

 Moderately Advanced

88 (19.6%)

80 (18.1%)

60 (18%)

54 (17%)

 Far Advanced

    
  1. *BMI- body mass index [weight in kg/ (height in cm)2]; #MDR- Multidrug resistant tuberculosis @WHO sputum grading - > 10 AFB/oil immersion field in at least 20 fields: 3+, 1–10 AFB/oil immersion field in at least 50 fields:2+, 10–99 AFB/ 100 oil immersion field:1+, 1–9 AFB/100 oil immersion field: Sc i.e., scanty);. $Radiographic severity at baseline not available for 1 patient.
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